PuraPly™ Antimicrobial XT Wound Matrix

Basic Information

• Brand Name: PuraPly™ Antimicrobial XT Wound Matrix
• Primary DI: 00618474000282
• Version / Model: 515-036
• Company Name: ORGANOGENESIS INC.
• Labeler DUNS: 152165817
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-10-01
• Public Version: 3
• Public Version Date: 2020-05-06
• Public Version Status: Update
• Public Device Record Key: 957307f5-f02a-4cac-9b49-8d2b674d8839

Device Description

PuraPly™ Antimicrobial XT Wound Matrix consists of a collagen sheet coated with 0.1% polyhexamethylenebiguanide hydrochloride (PHMB) intended for the management of wounds. PuraPly™ Antimicrobial XT Wound Matrix is supplied dry in sheet form. The device is packaged in sterile, sealed single pouches.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FRO	Dressing, Wound, Drug	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
45023	Collagen wound matrix dressing	A sterile, bioabsorbable, animal-derived collagen protein matrix designed to provide an occlusive/semi-occlusive cover for wound healing (non-oral) and/or a skin template of living cells (fibroblasts) and/or structural proteins to facilitate the infiltration of native skin elements (e.g., fibroblasts, leukocytes, blood vessels) for skin regeneration. The device is used for various types of partial- and full-thickness wounds, draining wounds, sores/ulcers, skin lacerations/abrasions, burns, and/or surgical wounds. It may combine collagen with other compounds or supplemental dressing materials (e.g., alginate); it is supplied in various forms. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00618474000282	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Width	9	Centimeter
Length	6	Centimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in a clean, dry location at room temperature
• Type: Special Storage Condition, Specify
• Special Conditions: Do not expose to temperatures above 120 degrees fahrenheit